Primary contact

ORCID ID

Contact details

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 98/11/04

Study information

Scientific title

Investigating if repetitive transcranial magnetic stimulation (rTMS) was as effective as electroconvulsive therapy (ECT) in treating major depressive episodes and performing a cost-effectiveness analysis.

Acronym

Study hypothesis

1. To carry out a multi-centre Randomised Controlled Trial (RCT), with 6 months follow-up, of repetitive Transcranial Magnetic Stimulation (rTMS) versus Electroconvulsive Therapy (ECT) in patients with severe depression. Ninety patients will be entered into each arm of the trial, sufficient to obtain a 95% confidence interval to demonstrate equivalence or a subtle difference between rTMS and ECT. The objectives are: 1.1. To determine if rTMS is as effective as ECT1.2. To determine if rTMS is associated with fewer side effects than ECT1.3. To identify patient characteristics indicative of a beneficial response to rTMS1.4. To ascertain patient preference for rTMS or ECT

2. To carry out a cost-effectiveness analysis of the use of rTMS versus ECT. The objectives are:2.1. To calculate the short and longer term costs of treatment with both rTMS and ECT2.2. To establish if there are any economic, as well as therapeutic, advantages in the use of rTMS compared to ECT in both the immediate and long term

Please note that, as of 16 January 2008, the start and end date of this trial have been updated from 1 May 2001 and 30 April 2004 to 1 August 2001 and 30 April 2005, respectively.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Depression, anxiety, neuroses

Intervention

1. Repetitive Transcranial Magnetic Stimulation (rTMS)2. ECT

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The following will be used to obtain baseline, intra-treatment and follow-up data as appropriate: 1. The Hamilton Rating Scale for Depression, Visual Analog Mood Scale, Brief Psychiatric Rating Scale2. Treatment side-effects and adverse events inventories3. Cambridge Cognitive Examination (CAMCOG) plus specific tests of memory and frontal-executive function4. Client Service Receipt Inventory and attendant methodologies for estimating unit costs of services and costs of treatment/care packages falling to the family and the NHS

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/08/2001

Overall trial end date

30/04/2005

Reason abandoned

Eligibility

Participant inclusion criteria

All in-patients referred for ECT with severe depressive episodes (Diagnostic Research Criteria [DCR-10]), including patients refractory to standard medical/psychological treatments